The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).
In this multi-centre, triple-blinded, non-inferiority trial 420 patients with TRD will be recruited at two academic centres (UBC, CAMH). Patients will be randomised to receive either iTBS or LFR for 30 sessions. The primary outcome will be the improvement on a depression scale. Secondary outcome will be improvement of suicidal ideation. A secondary aim is to test the predictive capacity of a novel, easy to implement heart rate based biomarkers (i.e. heart rate variability).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.
Intermittent Theta Burst Stimulation (iTBS)
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, Canada
RECRUITINGCentre for Addiction and Mental Health
Toronto, Ontario, Canada
RECRUITINGDepression severity
17 item Hamilton Depression Rating Scale (HDRS-17) Change
Time frame: 30 days
Suicidal ideation
Columbia Suicide Severity Rating Scale Screen Version (C-SSRS) Change
Time frame: 30 days
Anxiety severity
Hamilton Anxiety Rating Scale (HAM-A) Change
Time frame: 30 days
Depression severity
Self-rated 16-item Quick Inventory of Depressive Symptoms (QIDS-16) Change
Time frame: 30 days
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Low Frequency Right (LFR)